Evaluation and comparison of the effectiveness of kaleidoscope and virtual reality goggles to reduce dental anxiety in young children undergoing administration of local anesthesia.

Administration of local anesthesia via injection is the main reason for inducing anxiety in children and if not intervened it aggravates the anxiety in subsequent appointments. There are many approaches, including pharmacological and non-pharmacological methods that can be used to reduce children’s perception of pain and anxiety. A frequently used non-pharmacological behaviour management method to reduce anxiety and procedure pain is distraction. The rationale of distraction is to shift the attention to avert the brain from receiving unwanted stimulus which induce anxiousness. Many approaches including music, television, portable video games, virtual reality (VR) helmet, and virtual reality audio-visual eyewear, have been implemented so far. Kaleidoscope and virtual reality goggles may help as distraction techniques in reducing the levels of anxiety caused during administration of local anesthesia. By the aid of which the operator may be able to make the dental experience child friendly and ultimately provide quality dental care to anxious children. Non pharmacological measures of reducing pain are cost effective and best means that can be used while performing dental procedures. This is a research protocol for a study aimed to evaluate and compare the effectiveness of kaleidoscope and virtual reality goggles to reduce dental anxiety in young children.


Introduction
Anticipation of pain during dental treatment is a frequently reported reason for dental anxiety and fear.Dental anxiety comprises of various physical, mental as well as social components.Anxiety has been defined as a "vague, unpleasant feeling accompanied by a premonition that something undesirable is about to happen". 1 In the terms of Dental Fear and Anxiety (DFA), Dental anxiety is characterized as significant negative or unpleasant feeling about a dental office and dental procedures; whereas dental phobia is an irrational form of dental anxiety. 2 Dental anxiety is said to be a major contributor to poor oral health.Several studies have shown that the majority of significant triggers come from the sight, sound, and vibratory sensation of dental drills, and sensation of a local anaesthetic injection which is a major cause; subsequently dental fear is associated with past painful experiences and negative staff behaviour. 3An anxious patient is in a continuous state of restlessness and unease.Children experiencing anxiety during local anesthesia injection gives rise to a significant concern which thus necessitates cognitive -behavioural psychological guidance along with the needed dental treatment. 4There are many approaches, including pharmacological and non-pharmacological methods that can be used to reduce children's perception of pain and anxiety. 5,6Amongst which the procedures that focuses on cognitive or behavioural methods include practices such as listening to music, dreaming, hypnosis, use of virtual reality goggles, progressive muscle relaxation, and distraction through various interventional techniques. 7Attention refers to focusing and processing information from our surroundings.While in anxious state it is important to shift the child's attention away from the unpleasant stimuli.Distraction works on the principle of diverting the focus and blocking the reception of the unpleasant stimuli that causes anxiety.
Kaleidoscope is an instrument that shows an infinite number of fascinating geometric shapes in the form of a flower, repeating and reflecting images of coloured goggle fragments in the front section in a prism mirroring the inner surface.Increased blinking of the eyes is directly proportional to task difficulty, which in turn produces stress.In a relaxed situation, such as during kaleidoscope viewing, the number of blinks decreases and thus it controls the general physiological excitation. 8,9Kaleidoscope is being increasingly recognized for its therapeutic and healing value in medical procedures but very few studies on it are available for its use in pediatric dentistry.A study by Aditya et al. was conducted on the pediatric dental population with a kaleidoscope and virtual reality and a positive reduction in VPT scores and pulse rate was reported. 10rtual Reality (VR) is a human-computer interface that enables the user to communicate with the computer-generated atmosphere with dynamism.VR actively involves children and is a potent tool in helping children to keep their attention away from frightening and painful procedures.It allows the children to perceive the environment as a safe where they can be free without any risk. 10,11Atzori et al. (2017) found that VR technology reduced the mean "worst pain" from 3.80 to 2.20, hence indicating that VR can help effectively distract and engage children undergoing dental treatments. 12nce the focus of this study, according to the available literature, is to evaluate and compare the effectiveness of kaleidoscope and virtual reality goggles to reduce dental anxiety in young children.

Protocol
The aim of this study is to evaluate and compare the effectiveness of kaleidoscope and virtual reality goggles to reduce dental anxiety in young children undergoing administration of local anesthesia.
Objectives are: 1.To evaluate the effect of kaleidoscope to reduce dental anxiety levels in young children before and after the administration of local anesthesia.

REVISED Amendments from Version 3
This updated version of the article incorporates recent research findings regarding the use of kaleidoscope and virtual reality goggles to distract children during a local anaesthesia administration procedure in a dental setup.
This version includes-Updated techniques used in control group, randomization method and time frames for measuring the outcome parameters.
Any further responses from the reviewers can be found at the end of the article 2. To evaluate the effect of virtual reality goggles to reduce dental anxiety levels in young children before and after the administration of local anesthesia.
3. To compare effect of kaleidoscope and virtual reality goggles technique to reduce dental anxiety levels in young children before and after the administration of local anesthesia.
This parallel randomized multiple-arm clinical trial will be conducted in an isolated setup over a period of six months.
It will be a trial for equivalence.Children from five -eight years old who are healthy, co-operative but anxious.Children without any past dental experience those will undergo dental treatment requiring administration of local anesthesia for procedures like pulpectomy or extractions will be included in the study.Children with known vision problems, psychological abnormalities, children with special health care needs, children suffering from systemic diseases, and the parents that are unwilling to participate will be excluded from the study.
Group 1 -Kaleidoscope: The children will be given a kaleidoscope having various changing colours and patterns to watch through just before the starting of the procedure and will be asked to watch through it until the procedure ends.
Group 2 -Virtual reality goggles technique: The children will be asked to wear Virtual Reality goggles and a video to keep the child engaged will be played by clicking on the remote control.VR will be given just before the starting of the procedure and will be asked to watch through it until the procedure ends.
Group 3 -Control group wherein usage of basic behavior guidance techniques like tell-show-do, ask-tell-ask, positive reinforcement, modelling, systemic desensitization and voice control will be employed.
It is a randomized clinical trial.This is a version 1 of the protocol.Sequence generation by lottery method will be generated.The co-investigator of the department will generate the allocation sequence and will assign participants to interventions.It will be a double-blind study where trial participants, data analysts will be blinded.Data management by double data entry will be done.Personal information about potential and enrolled participants will be collected and maintained in order to protect confidentiality before, during, and after the trial.Comparators Kaleidoscope, Virtual reality goggles technique and conventional behaviour management method will be taken into consideration for comparing as all of them are interventions aiding for reducing the anxiety levels.
The sample size calculation is based on previous research by Aditya et al. 13 that used a similar study technique by using the sample size formula for difference between two means, A total of 60 children will be included for the study.The participants in each group will be allocated by simple random sampling.
VFAS score using a validated Visual Facial Anxiety Scale is the primary outcomes to be measured.Pulse oximeter to measure physiological signs of oxygen saturation, and pulse rate, respiratory rate are the secondary outcomes to be measured.All the outcomes will be measured before, during, and immediately after the LA intervention.

Data analysis and statistical plan
Analytical tests like Chi square test and student's t-test will be performed.All the statistical analysis will be performed using SPSS software, version 27.0 p<0.05 will be considered as the level of significance.This randomized clinical trial will be conducted at the Department of Pediatric and Preventive Dentistry, Sharad Pawar Dental College, Datta Meghe Institute of Higher Education and Research, Wardha.The allocation will be done using lottery method.

Dissemination
Once completed the study will be published in a PubMed, Scopus indexed journal.

Discussion
There is a limited literature available regarding the use kaleidoscope as a distraction method for children undergoing dental procedures.Aditya et al. conducted a study to compare various methods of distraction to control anxiety in 60 children between the age group of six -nine years divided into four groups.Group 1 was fidget spinner (FS), Group 2 was kaleidoscope, Group 3 Virtual reality and Group 4 was control group with no distraction.The child's self-reported anxiety levels using Venham's picture test (VPT); the pulse oximeter was used to measure physiological signs of oxygen saturation and pulse rate at three intervals i.e. before, during, and after the IANB procedure.The VPT values were lower in the first three groups.Hence it was concluded that Fidget spinner, kaleidoscope, and virtual reality seem to be effective distraction methods and can be recommended as effective approaches to help reduce children's dental anxiety during IANB procedures. 13Tailor et al. found out that when Virtual reality (VR) and on-screen audio-visual distraction techniques were used in the age group of 4-8 years the VPT scores were significantly reduced in VR group as compared to On-screen aid group in the first two visits that included procedures of screening, cavity preparation and L.A. administration. 14The effect of cartoon display and kaleidoscope in children between the ages of 5-12years was assessed and the anxiety levels were scored using Children's Fear Scale by Molu and Açıkgöz, during echocardiography procedure.A significant difference is evident in anxiety scores before and during between all the intervention groups and it was concluded that use of kaleidoscope is an effective measure in reducing anxiety. 15Distraction by Kaleidoscope and VR is a promising area for future research in pediatric dentistry because of the rising interest in non-pharmacological methods for behaviour management.The study protocol will be explained to the participating children and their parents.

Ethical considerations
Further, a written informed consent will be obtained from their parents.

Introduction
The study proposal aims to compare the effectiveness of a kaleidoscope and virtual reality goggles in reducing dental anxiety in children during local anesthesia administration.Dental anxiety is a significant issue affecting oral health, with various triggers and potential interventions mentioned in the proposal.

Identification of Gap in Literature
The proposal successfully identifies a gap in the literature concerning the use of kaleidoscope as a distraction method in pediatric dentistry.However, the gap regarding VR goggles is less pronounced, as there is already substantial evidence supporting its effectiveness.

Soundness and Rigor of the Proposal
Strengths: The study addresses a pertinent issue in pediatric dentistry.

○
The use of kaleidoscope and VR goggles as non-pharmacological interventions is innovative and has potential therapeutic value.

○
Weaknesses: The literature review, while comprehensive, lacks critical analysis of the cited studies.It should delve deeper into the methodologies and limitations of the referenced research to build a stronger case for the proposed study.

○
The proposal lacks a clear theoretical framework explaining why these particular interventions are chosen and how they are hypothesized to work in reducing dental anxiety.

Methodology Strengths:
The use of a randomized, double-blind clinical trial design is robust and enhances the reliability of the results.

○
The sample size calculation based on previous research is appropriate.

Weaknesses:
The exclusion criteria are broad, potentially limiting the generalizability of the findings.For instance, excluding children with past dental experiences might omit a significant portion of the target population.

○
The control group lacks a detailed description of the "basic behavior guidance techniques" to be employed, which could lead to inconsistencies in the control conditions.○

Reliability and Validity of the suggested methodology
Strengths: Double-blinding enhances the internal validity of the study.

○
The use of VFAS scores and physiological measures (pulse oximeter readings) is appropriate for assessing anxiety levels.

○
Weaknesses: The proposal does not specify the exact timing of data collection (e.g., how long after the procedure the anxiety levels will be measured).

○
The lottery method for randomization, while simple, may not be as effective in ensuring complete randomness compared to computerized randomization techniques.○

Suggestions for Improvement
Conduct a more in-depth analysis of existing studies, highlighting their methodologies, findings, and limitations.Reconsider the exclusion criteria to include children with past dental experiences to enhance generalizability.

○
Consider using computerized randomization methods to ensure complete randomness and reduce potential biases.
○ Specify the exact timing of anxiety measurements to standardize the data collection process. ○

Overall assessment
This study proposal is well-structured and addresses an important issue in pediatric dentistry.While the methodology is robust, there are areas for improvement in the literature review, theoretical framework, and control group definition.By addressing these areas, the study can significantly contribute to the understanding and management of dental anxiety in children.
Is the rationale for, and objectives of, the study clearly described?Yes

Is the study design appropriate for the research question? Partly
Are sufficient details of the methods provided to allow replication by others?Partly

Are the datasets clearly presented in a useable and accessible format? Yes
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: Dental Education, Oral precancer, Oral Cancer, Salivary glands, facial injuries I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.
techniques used in the control group.4. The children with past dental experiences are excluded because the behaviors and responses to dental procedures are shaped by these experiences, which may influence the outcomes of our study.5. Due to limited access to specific software, for the due course of this study lottery method was assigned.6.The exact timing of anxiety measurements to standardize the data collection process is updated.
I have uploaded version 4 with the modifications as quoted.
Is the rationale for, and objectives of, the study clearly described?Yes

Is the study design appropriate for the research question? Yes
Are sufficient details of the methods provided to allow replication by others?Partly Are the datasets clearly presented in a useable and accessible format?

Not applicable
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: Public Health Dentistry, Oral Health, Oral Pathology, Mental Health, Noncommunicable diseases.
I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.
Ethical approval for the study was obtained from the Institutional ethics committee of Datta Meghe Institute of Medical Sciences (Deemed to be University) [ref no: DMIMSU (DU)/IEC/2022/756].

○
Develop a theoretical framework to explain the expected mechanisms through which kaleidoscope and VR goggles reduce dental anxiety.○Provide a detailed protocol for the behavior guidance techniques used in the control group ○ to ensure consistency.